Livewire™ 401904Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05414734202534), received between Jul 20, 2020 and Aug 8, 2024 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Entrapment of Device” (7 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryAug 8, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE PHYSICIAN WAS UNABLE TO PUT THE CATHETER INTO THE CORONARY SINUS BECAUSE THE CATHETER WOULD NOT DEFLECT AS EXPECTED. THE CATHETER WAS REMOVED FROM THE PATIENT AN UNKNOWN SUBSTANCE WAS NOTED TO BE ATTACHED TO THE DISTAL END DEVICE. THE CATHETER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE CATHETER WAS NOT PROPERLY INSPECTED BY STAFF WHEN IT WAS OPENED BUT THE SALES REP SUSPECTS THAT TISSUE IN THE HEART MAY HAVE BEEN ACCIDENTALLY CAUGHT BY THE CATHETER. THE CUSTOMER SUSPECTED THAT THE SUBSTANCE SHOWN IN THE PICTURE IS THE CATHETER COATING.

  Patient problems: Foreign Body In Patient

  MAUDE report 19937659 ↗
• InjuryMar 5, 2024Entrapment of Device; Entrapment of Device

  DURING A REDO PULMONARY VEIN ISOLATION AND CTI LINE PROCEDURE, THE DIAGNOSTIC CATHETER BECAME STUCK IN THE RIGHT ATRIUM AT THE TIP AND AROUND POSITION OF ELECTRODE 19-20. IT IS UNKNOWN WHAT CAUSED THE ENTRAPMENT. DUE TO MANIPULATION THE DIAGNOSTIC CATHETER WAS BENT 1CM PROXIMAL OF ELECTRODE 19-20. THE ABLATION CATHETER WAS THEN INSERTED TO TRY TO FREE THE TIP. THIS DID NOT WORK SO THE SHEATH WAS ADVANCED OVER THE DIAGNOSTIC CATHETER FOR MORE SUPPORT. TO DO SO THE HANDLE OF THE DIAGNOSTIC CATHETER WAS CUT AND A SUTURE WAS FIXATED TO THE END. THIS WAS DONE IN ORDER TO USE THE SHEATH TO SLIDE OVER THE DIAGNOSTIC CATHETER FOR MORE SUPPORT. THE SUTURE WAS USED TO EXTEND THE GRIP OF THE DIAGNOSTIC CATHETER WHILE SLIDING THE SHEATH OVER THE DIAGNOSTIC CATHETER. THE SHEATH AND DIAGNOSTIC CATHETER WERE THEN MANIPULATED TO FREE THE CATHETER TIP. ONCE THE DIAGNOSTIC CATHETER WAS FREED, NO TISSUE WAS SEEN AT THE TIP OF THE CATHETER. THE PHYSICIAN ALLEGES THAT THE CATHETER WAS ENTANGLED IN THE CHORDAE OF THE TRICUSPID VALVE. A TRANSESOPHAGEAL ECHOCARDIOGRAM SHOWED THERE WERE NO INJURIES. THE PROCEDURE WAS TERMINATED, AND PATIENT WENT BACK TO THE WARD TO BE MONITORED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18839478 ↗
• InjuryFeb 27, 2024Entrapment of Device; Entrapment of Device

  DURING THE PROCEDURE, ELECTRODES 19-20 AND 3-4 BECAME PHYSICALLY STUCK TOGETHER INSIDE THE HEART AND WOULD NOT COME APART. A SNARE WAS USED TO SEPARATE THEM AND REMOVE THE CATHETER FROM THE PATIENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18789083 ↗
• MalfunctionNov 8, 2023Entrapment of Device; Entrapment of Device

  DURING AN ATRIAL FLUTTER PROCEDURE, POSITIONING ISSUES WITH THE CATHETER REQUIRED TROUBLESHOOTING MEASURES AND RESULTED IN THE PROCEDURE BEING ABORTED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE CATHETER WAS INTRODUCED VIA RIGHT FEMORAL ACCESS AND POSITIONED INTO THE RIGHT ATRIUM. DIFFICULTY WAS NOTED WHEN ATTEMPTING TO PLACE THE CATHETER TIP INTO THE CORONARY SINUS. ATTEMPTS TO PLACE OTHER CATHETERS INTO THE CORONARY SINUS WERE ALSO UNSUCCESSFUL. AN HOUR INTO THE PROCEDURE, IT WAS NOTED THAT THE CATHETER WAS ENTANGLED IN THE RIGHT ATRIUM. DIFFERENT MANEUVERS WERE PERFORMED AND THE CATHETER WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS ABORTED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18092711 ↗
• InjuryMar 15, 2023Entrapment of Device; Entrapment of Device

  DURING INSERTION OF THE CATHETER, IT BECAME STUCK IN THE ATRIUM AND THE PULL WIRES BROKE. A SNARE WAS USED TO REMOVED THE CATHETER. THE CATHETER WAS RETAINED BY THE CUSTOMER.

  Patient problems: Foreign Body In Patient

  MAUDE report 16550882 ↗
• InjuryFeb 2, 2022Entrapment of Device; Entrapment of Device

  DURING A PREMATURE VENTRICULAR CONTRACTIONS (PVC) ABLATION PROCEDURE, THE CATHETER WAS PLACED IN THE RIGHT ATRIUM AND WHILE ATTEMPTING TO CANNULATE THE CORONARY SINUS, THE CATHETER COULD NOT BE STRAIGHTENED COMPLETELY AND COULD NOT BE REMOVED FROM THE RIGHT ATRIUM. THE LOOP OF THE CATHETER WAS TOO LARGE TO PULL INTO THE INFERIOR VENA CAVA (IVC). AFTER APPROXIMATELY TWO HOURS, THE CATHETER WAS ABLE TO BE MANIPULATED AND THE LOOP WAS STRAIGHTENED WITH THE USE OF AN ABLATION CATHETER AND STEERABLE SHEATH. THE CATHETER WAS REPLACED WITH ANOTHER CATHETER FROM THE SAME MODEL AND LOT TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13423881 ↗
• InjuryDec 15, 2021Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  DURING A SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE, THE CATHETER BECAME BENT AND A SNARE WAS NEEDED TO REMOVE THE DEVICE. THE CATHETER WAS PLACED INTO THE RIGHT ATRIUM, THE ACTUATOR HANDLE WAS TURNED TO PLACE INTO THE DEVICE INTO THE CORONARY SINUS (CS). THE PHYSICIAN STATED THE PATIENTS ATRIUM WAS NORMAL SIZE AND HE WAS HAVING DIFFICULTIES CANNULATING THE CS. AN ATTEMPT TO STRAIGHTEN THE CURVE OF THE CATHETER WAS UNSUCCESSFUL. THE DEVICE WAS ABLE TO BE ROTATED 360 DEGREES WITHOUT RESISTANCE. THE CATHETER COULD NOT BE ADVANCED INTO THE SVC, IVC, OR RV, WHEN ATTEMPTING TO STRAIGHTEN AND REMOVE THE CATHETER. AFTER ATTEMPTING TO REMOVE THE CATHETER FOR APPROXIMATELY 30 MINUTES, A SNARE WAS PLACED INTO THE RIGHT ATRIUM AND ATTACHED TO THE DISTAL PORTION OF THE CATHETER. WHILE HOLDING THE DISTAL PORTION STABLE, THE CATHETER WAS ABLE TO BE REMOVED. THE CATHETER WAS REPLACED WITH A DEVICE FROM THE SAME MODEL WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13011834 ↗
• InjuryMar 8, 2021Entrapment of Device; Entrapment of Device

  DURING THE PROCEDURE, WHEN ATTEMPTING TO POSITION THE CATHETER INTO THE CORONARY SINUS IT BECAME ENTANGLED ON ITSELF AND A SNARE WAS USED FOR REMOVAL. ELECTRODES 5-6 APPEARED TO BE CAUGHT ON ELECTRODES 19-20. SEVERAL DIFFERENT WAYS TO WERE TRIED TO RELEASE THE DEVICE WITH NO SUCCESS. SEVERAL CATHETERS WERE ATTEMPTED TO PASS THROUGH THE CENTER OF THE LOOP ON THE LIVEWIRE UNSUCCESSFULLY. AFTER APPROXIMATELY AN HOUR, A SNARE CATHETER WAS USED WITH FORCE AND THE CATHETER WAS UNTANGLED AND REMOVED FROM THE PATIENT. THE PATIENT HAD TOO MUCH X-RAY AND HAD BEEN UNDER ANESTHESIA FOR TOO LONG AND THE CASE WAS CANCELLED. VISIBLE KINKS WERE NOTED WHERE THE CATHETER WAS CAUGHT ON ITSELF. THE PATIENT WAS NOT HARMED BUT DID RECEIVE SEVERAL X-RAYS AND WAS UNDER GENERAL ANESTHESIA FOR A FEW HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11440358 ↗
• InjuryNov 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBERS: 3008452825-2020-00567; 2182269-2020-00093. DURING A RIGHT VENTRICULAR OUTFLOW TRACT PREMATURE VENTRICULAR CONTRACTION ABLATION, A PERICARDIAL EFFUSION WAS OBSERVED AND THE PROCEDURE WAS CANCELLED. WHILE ABLATING THE ANTERIOR ASPECT, HYPOTENSION WAS NOTED, AND A PERICARDIAL EFFUSION WAS FOUND VIA ULTRASOUND. THE CASE WAS ABANDONED, AND A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT.

  Patient problems: Cardiac Perforation

  MAUDE report 10800567 ↗
• InjuryOct 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REPORT NUMBERS: 3005334138-2020-00465, 3005334138-2020-00466, 3008452825-2020-00521, 2030404-2020-00083. AT THE END OF A PVC ABLATION PROCEDURE, DURING RF OF THE LAST LESION, A PERICARDIAL EFFUSION OCCURRED. THE DUO CATHETER WAS PLACED IN THE CORONARY SINUS AND THE FLEXIBILITY WAS USED FOR ABLATION OF THE PVC'S IN THE RIGHT VENTRICLE. REINFORCEMENT OF THE LESIONS IN THE RIGHT VENTRICLE WERE VERIFIED TO CONFIRM ELIMINATION OF THE ARRHYTHMIA. HOWEVER, THE PATIENT BECAME HYPOTENSIVE AND AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 10669300 ↗
• InjuryJul 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE: 3005334138-2020-00310, 3008452825-2020-00356, 2030404-2020-00052. FOLLOWING A TYPICAL FLUTTER ABLATION, A PERICARDIAL EFFUSION OCCURRED. AS PATIENT WAS BEING WOKEN UP FROM ANESTHESIA, THE PATIENT BECAME HYPOTENSIVE AND RHYTHM WENT FROM SINUS TO AFIB DURING PACING. AN ULTRASOUND CONFIRMED A PERICARDIAL EFFUSION. PHENYLEPHRINE, VITAMIN K AND 2 UNITS OF FFP WERE ADMINISTERED. IT WAS INDICATED THE CAUSE MAY HAVE BEEN THE MOVEMENT OF THE DUODECA CATHETER AND ABLATION OF THE CAVO-TRICUSPID ISTHMUS , HOWEVER THE CAUSE AND LOCATION OF THE EFFUSION REMAINS UNKNOWN. NO FURTHER INTERVENTION WAS NEEDED AND THE PATIENT WAS STABILIZED. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 10296331 ↗